BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 392872 · Received May 3, 2002

    Report

    Report Number
    1720159-2002-00026
    Event Type
    Malfunction
    Date Received
    May 3, 2002
    Date of Event
    March 5, 2002
    Report Date
    April 5, 2002
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DIR. OF CLINICAL ENGINEERING SAID WHEN USING THEIR NEWLY PURCHASED ERBE ESU WITH THE CO 130307 CONMED PENCIL, WHEN KEYING IT, IT BURST INTO FLAMES. THEY TRIED ANOTHER PENCIL AND IT DID THE SAME. THIS HAPPENED ABOUT 3/2002. THEN ABOUT TWENTY SIX DAYS LATER THEY TRIED ANOTHER CONMED PENCIL, 130307, WITH THE ERBE ESU AND THE PENCIL FLAMED AGAIN. REFER TO MFR REPORT NUMBERS: 1720159-2002-00026, 00027 AND 00028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROSURGICAL PENCIL GEI CONMED ELECTROSURGERY CONMED PENCIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA ERBE ESU.